WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 6.2.4.1-AE: Report to the NRA serious public health threats, deaths or serious deteriorations in health, and failures or design, labelling or use problems that could cause them, plus any false negative for a Class D IVD; investigate reports passed on by the NRA and report the outcome

What does 6.2.4.1-AE require?

Manufacturers, directly or through their authorized representative, should be legally required to tell the NRA about events linked to their device in the jurisdiction where a serious public health threat is discovered; where a patient, user or other person dies or suffers serious deterioration in health; or where there was no such harm but a failure, malfunction, inadequate design, manufacture or labelling, or a use error could have led to it. For IVDs, any false negative result for a Class D test is reportable. Reports received by the NRA from users or inspections are passed to the manufacturer or representative for investigation and trend analysis, and the manufacturer should tell the NRA what the investigation found and take actions such as a field safety corrective action or field safety notice where needed. Reporting thresholds, time limits, content and responsible parties should follow WHO and IMDRF guidance.